PaxVax chikungunya vaccine receives fast-track status from FDA
PaxVax Inc. announced that its candidate vaccine to prevent chikungunya virus infection has received fast-track status from the FDA.
The fast-track designation is used to speed up the development of drugs that may treat a serious condition and fill an unmet medical need to get them into the hands of patients earlier.
Chikungunya, a mosquito-borne disease with sometimes debilitating symptoms that can last for months or even years, was not documented in the Americas until 2013. But since its introduction, it has caused more than 2 million suspected infections.
According to the CDC, there are no licensed vaccines or specific treatments to prevent or treat chikungunya infection.
PaxVax licensed the virus-like particle vaccine from the National Institute of Allergy and Infectious Diseases and recently announced that it has started the process of enrolling 400 people in a phase 2b dose-finding trial, which follows phase 1 and 2 trials conducted by the NIH.
"This fast-track designation is another positive step for the development of our chikungunya vaccine, in addition to our recent phase 2b initial patient enrollment, and is a clear recognition of the serious unmet need," Lisa Danzig, MD, chief medical officer of PaxVax, said in a news release. "This is another example of the capabilities of our technology platform and our steadfast commitment to developing specialty vaccines that protect against overlooked infectious diseases as mosquito-borne diseases continue to increase due to air travel and warmer weather."
Disclosures: Danzig works for PaxVax.